Hexyl aminolevulinate - Photocure

Drug Profile

Hexyl aminolevulinate - Photocure

Alternative Names: 5-ALA hexylester; 5-ALA hexylesther; aminolevulinic acid hexyl ester; Cevira; Cysview; HAL-PDT; hexaminolevulinate; Hexvix; Hexvix PDT; hexyl 5-aminolevulinate; P 1206

Latest Information Update: 20 Oct 2017

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At a glance

  • Originator PhotoCure
  • Developer Ipsen; Juno Pharmaceuticals; Photocure
  • Class Amino acids; Antineoplastics; Esters; Levulinic acids; Oxidants; Small molecules
  • Mechanism of Action Photosensitisers
  • Orphan Drug Status

    Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.

  • New Molecular Entity No
  • Available For Licensing Yes - Cervical intraepithelial neoplasia

Highest Development Phases

  • Marketed Bladder cancer
  • Phase II Cervical intraepithelial neoplasia
  • Discontinued Colorectal cancer

Most Recent Events

  • 18 Oct 2017 Photocure anticipates the approval of sNDA in the US for use of BLC™ with Cysview® using KARL STORZ D-Light C PDD Flexible Videoscope System for the diagnosis of Bladder cancer in the first half of 2018
  • 18 Oct 2017 US FDA accepts sNDA and grants priority review status for hexyl aminolevulinate for Bladder cancer (Diagnosis)
  • 16 Aug 2017 Photocure submits sNDA to US FDA to seek approval for use of BLC™ with Cysview® using KARL STORZ D-Light C PDD Flexible Videoscope System, for the diagnosis of Bladder cancer, to expand the indication to include detection of carcinoma in situ and to allow for repeated use
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